Bard wins FDA panel date for Lutonix balloon

May 20, 2014 by Brad Perriello

C.R. Bard won a date for an FDA panel review next for its Lutonix drug-eluting balloon in treating peripheral artery disease, ahead of its bid for approval to put the device on the U.S. market.

The FDA’s Circulatory System Devices Panel is slated to meet June 12 to review Bard’s pre-market approval application for the Lutonix balloon, which is coated with the anti-restenosis drug paclitaxel. Read more

Johns Hopkins and UCSF-Stanford join FDA’s Centers of Excellence in Regulatory Science and Innovation

May 20, 2014 by MassDevice

The Commissioner's Fellowship Program: A win-win for FDA and public health

By Dr. Stephen M. Ostroff

If you’ve been following my blog series about the Office of the Chief Scientist (OCS), you know about a critical component of nearly all FDA efforts to promote innovative approaches to developing and evaluating our regulated products – collaboration! This week FDA made two new additions to its network of academic partnerships known as Centers of Excellence in Regulatory Science and Innovation (CERSIs).

The first partner brings together a team of leading scientists at the University of California at San Francisco (UCSF) in a joint effort with Stanford University. The second, Johns Hopkins University, builds on a long history of collaboration with FDA. Both partners received FDA funding through a competitive application process to establish CERSIs that will promote cross-disciplinary regulatory science training, scientific exchanges, and leading-edge research focused on FDA science priority areas. Read more

FDA warns CardiacAssist on unreported patient death

May 22, 2014 by Arezu Sarvestani

Pennsylvania-based CardiacAssist landed in the FDA’s cross hairs this month after agency inspectors found that the company failed to file a report after learning of a patient death.

The FDA said that CardiacAssist failed to notify regulators of a patient who died while on the company’s TandemHeart pump. The pump stopped turning after 10 days and attempts to restart it were unsuccessful. The patient died a few days later, according to the FDA memo. Read more

Building expertise and crossing boundaries to improve oversight

May 22, 2014 by MassDevice

By Howard Sklamberg, J.D.

As FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.

GO coordinates the efforts of FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of FDA’s product centers on scientific, manufacturing or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections, deepening collaborations with local, state and foreign regulatory partners, helping these regulatory partners to strengthen their regulatory systems, and fostering the use of science-based standards and regulatory coherence around the globe to promote the public health of our citizens. Read more

FDA warns on infant CPAP systems following dozens of complaints

May 23, 2014 by Arezu Sarvestani

FDA warns on infant CPAP systems following multiple complaints

FDA regulators put their highest-level warning on Fisher & Paykel’s recall of infant CPAP components, warning that the defect may pose a choking risk to babies.

F&P initiated the recall last month after receiving 24 reports that infant nasal CPAP prongs had malfunctioned. The prongs had detached from tubing, interrupting therapy and potentially causing low blood oxygen. The prongs may also fall into babies’ mouths, where they may block airways, according to the FDA memo. Read more